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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number 990063-020
Device Problem Entrapment of Device (1212)
Patient Problems Physical Entrapment (2327); Blood Loss (2597)
Event Date 08/23/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, the mapping catheter could not be removed from the left superior pulmonary vein (lspv).A transesophageal echocardiogram (tee) was performed to confirm entrapment.The patient was taken into the operating room to remove the mapping catheter.The case was aborted and the patient was under general anesthesia.No further patient complications have been reported as a result of this event.Post procedure, the patient underwent a blood transfusion due to blood loss but is currently stable.
 
Manufacturer Narrative
Event summary: patient data files showed ten applications were performed with catheter 2af284/4062 the date of event.Patient file showed system notice (50003) was received indicating that the pressure was low in the system at application #1 and 2, most likely due to closed gas tank.The mapping catheter performance is not captured through patient data file.The case was aborted and the patient was under general anesthesia.It was reported that during a cryo ablation procedure, the mapping catheter could not be removed from the left superior pulmonary vein (lspv).The patient was taken into the operating room to remove the mapping catheter.The case was aborted and the patient was under general anesthesia.The mapping catheter was not returned for investigation.In conclusion, this is a case related to a clinical adverse event (entrapment).The reported issue could not be assessed through data analysis.There is no indication of relation of adverse event to the performance and malfunction of the product.The mapping catheter was not returned for investigation.The case was aborted while the patient was under general anesthesia.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
ACHIEVE MAPPING CATHETER
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA  H9R 5Z8
Manufacturer (Section G)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA   H9R 5Z8
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7877814
MDR Text Key120310689
Report Number3002648230-2018-00656
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162892
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number990063-020
Device Catalogue Number990063-020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/23/2018
Initial Date FDA Received09/14/2018
Supplement Dates Manufacturer Received10/02/2018
Supplement Dates FDA Received10/29/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
Patient Weight67
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